Evaluation of the Safety and Tolerability of Ocular Lubricants

Not Applicable

Not yet recruiting

• Conditions: Dry Eye Disease

• Registration Number: NCT06571656
• Lead Sponsor: Alcon Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Key Inclusion Criteria:<br><br> - Willing and able to understand and sign an Ethics Committee-approved informed<br> consent form.<br><br> - Willing and able to attend all study visits as required by the protocol.<br><br> - Exhibits symptoms of dry eye at the Screening Visit.<br><br> - Currently uses habitual artificial tears to alleviate dry eye symptoms.<br><br> - Willing and able to maintain similar environmental conditions throughout the study<br> (for example, avoid extreme changes in humidity/temperature, avoid windy conditions)<br> and refrain from swimming on Investigational Product visit days.<br><br> - Other protocol-specified inclusion criteria may apply.<br><br>Key Exclusion Criteria:<br><br> - Has any known active ocular disease and/or infection.<br><br> - Has any known infection or inflammation that requires treatment or has a systemic<br> condition that in the opinion of the investigator, may affect a study outcome<br> variable.<br><br> - Has had an ocular injury to either eye in the past 12 weeks prior to screening.<br><br> - Currently wears contact lenses or has a history of contact lens wear within the<br> previous 1 month.<br><br> - Has undergone any ocular surgery (including intraocular surgery) within the past 12<br> months or has any ocular surgery planned during the study.<br><br> - Is pregnant, intends to become pregnant, or is breastfeeding.<br><br> - Other protocol-specified exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Treatment-Emergent Adverse Events (AEs);Number of Subjects with Biomicroscopy Findings Outside of Normal Limit;Best Corrected Visual Acuity (BCVA) with Manifest Refraction (MR)